EP1568480A2 - Méthode et dispositif pour le contrôle de qualité dans la fabrication de comprimés - Google Patents

Méthode et dispositif pour le contrôle de qualité dans la fabrication de comprimés Download PDF

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Publication number
EP1568480A2
EP1568480A2 EP04030542A EP04030542A EP1568480A2 EP 1568480 A2 EP1568480 A2 EP 1568480A2 EP 04030542 A EP04030542 A EP 04030542A EP 04030542 A EP04030542 A EP 04030542A EP 1568480 A2 EP1568480 A2 EP 1568480A2
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EP
European Patent Office
Prior art keywords
sensor
nir
tablets
tablet press
lif
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
EP04030542A
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German (de)
English (en)
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EP1568480A3 (fr
EP1568480B1 (fr
Inventor
Jürgen Hinzpeter
Ingo Schmidt
Ulrich Gathmann
Jörg Gaedecke
Werner Seifert
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Fette Compacting GmbH
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Fette GmbH
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Publication of EP1568480A3 publication Critical patent/EP1568480A3/fr
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    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/17Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/25Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands
    • G01N21/31Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry
    • G01N21/35Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry using infrared light
    • G01N21/359Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry using infrared light using near infrared light
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B30PRESSES
    • B30BPRESSES IN GENERAL
    • B30B11/00Presses specially adapted for forming shaped articles from material in particulate or plastic state, e.g. briquetting presses, tabletting presses
    • B30B11/005Control arrangements
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B30PRESSES
    • B30BPRESSES IN GENERAL
    • B30B11/00Presses specially adapted for forming shaped articles from material in particulate or plastic state, e.g. briquetting presses, tabletting presses
    • B30B11/02Presses specially adapted for forming shaped articles from material in particulate or plastic state, e.g. briquetting presses, tabletting presses using a ram exerting pressure on the material in a moulding space
    • B30B11/08Presses specially adapted for forming shaped articles from material in particulate or plastic state, e.g. briquetting presses, tabletting presses using a ram exerting pressure on the material in a moulding space co-operating with moulds carried by a turntable
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/17Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/25Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands
    • G01N21/31Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry
    • G01N21/35Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry using infrared light
    • G01N21/3563Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry using infrared light for analysing solids; Preparation of samples therefor
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/62Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light
    • G01N21/63Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light optically excited
    • G01N21/64Fluorescence; Phosphorescence
    • G01N21/6402Atomic fluorescence; Laser induced fluorescence
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/84Systems specially adapted for particular applications
    • G01N21/88Investigating the presence of flaws or contamination
    • G01N21/95Investigating the presence of flaws or contamination characterised by the material or shape of the object to be examined
    • G01N21/9508Capsules; Tablets

Definitions

  • the invention relates to a method for quality control during manufacture of tablets in a rotary tablet press according to claim 1.
  • Rotary tablet presses are well known and diversified in the used in the pharmaceutical industry. They have a rotor, which is usually around a vertical axis of rotation is driven and upper and lower punches, dies, Matrizenin and curve systems and at least one printing station has. When the rotor rotates, the curve system ensures the vertical positioning of Upper and lower stamp on the circle.
  • the filling of the matrices with powdered Pressing material takes place with the aid of suitable filling systems, for example one Stirring device or a filling shoe, with which the matrices continuously be filled with rotating rotor.
  • suitable filling systems for example one Stirring device or a filling shoe
  • pre and main pressure rollers with the help of the press material to a Tablet is pressed.
  • the ejection of the tablets from the matrices is carried out with Help of the associated lower punch, which is actuated by an ejector curve.
  • the tablets must meet quality criteria. These include z. Weight, Hardness, breaking strength, tablet height, drug content, drug release, disintegration, Friability, porosity, surface area, moisture content, etc. It is known a quality control in the way that carry out the tablet production Samples are taken. They are in the laboratory with suitable testing equipment checked. The disadvantage here is that naturally only a fraction of the produced Tablets is tested. The manual effort and the time required are great.
  • the invention is based on the object, a method for quality monitoring in the manufacture of tablets in a rotary tablet press, the Working online, checking all the tablets and capturing a variety of important quality parameters without having to destroy the tablets.
  • At least some chemical or mechanical property data of the tablets using at least one near-infrared sensor or a laser fluorescence sensor in the press room after the Oberstempel leave the matrices, won after a measurement of a machine computer as a function of determined by a position sensor Matrizenposition triggered relative to the near-infrared or laser fluorescence sensor has been.
  • the so-called near-infrared spectroscopy (NIR) or laser fluorescence spectroscopy (LIF) is a known measuring method for the determination of Properties of pharmaceutical substances, including tablets. For the application it requires a light or radiation source and a receiver, the existing light or its spectrum absorbs the desired data and transmitted.
  • the individual Tablets or assigned to their position at the time takes place after the Stamp the press the tablet pressed and the punch the die has left.
  • the tablet must still be stationary relative to the die plate and may not yet be loose on the surface of the die plate.
  • the sensor z. B. the end face and also a part of the lateral surface capture the tablet.
  • the measuring process takes place either after the reflection or the transmission method.
  • the transmission method does not come then more for use if the tablet is too thick or too large a diameter Has.
  • the measuring process is triggered by the machine computer, which is present anyway for the operation of the rotary tablet press.
  • each single tablet d. H. their frequency spectra are from the machine computer or an auxiliary computer connected to the sensor, recorded and after known methods, such. As the chemometry, are evaluated.
  • the measurement results about the mechanical and / or chemical properties of the tablet such as B. drug identity and / or drug content and / or content of additives and / or density and / or hardness and / or breaking strength and / or porosity and / or other relevant measurable quality parameters are used to statistical calculations, such as B.
  • setpoint deviations of the quality data such as B. on active ingredient content and / or density and / or hardness and / or breaking strength and / or porosity are used to optimize machine setting parameters, such as B. speed of the rotor and / or speed of the filling system and / or filling depth and / or tablet web height and / or measure of the immersion depth.
  • the powdered molding material is already before its compression in terms of quality-relevant parameters, such.
  • the on the machine computer or the additional calculator given measurement results can either be displayed and / or logged and / or when exceeding a predetermined limit range lead to a stop of the machine.
  • they can be processed statistically and / or used to control the tablet press.
  • the invention allows compared to the previously known quality control procedures a fast and non-destructive measuring method. It can be every single tablet being checked. But it is also possible to control part of the tablets. Since the measurement results are available immediately, a fast process optimization with Help suitable control circuits possible. Another advantage is that immediate Release of the produced batch is possible. In conventional methods a more or less large gap between production and release a batch. The invention enables an early interruption of the Production process at borderline violations of quality parameters or Release of a batch. Overall, process reliability is improved while at the same time Reduction of the process costs. It is understood that in addition to the invention Method may also be a conventional sample measurement, which with regard to individual parameters leads to precise results.
  • FIG. 1 for example, a rotary tablet machine is generally shown, d. h., The pressing space of this machine, of the details with reference to Figure 2 to be briefly described.
  • a part of a rotor 12 is indicated, the is driven to rotate about a vertical axis (not shown).
  • the rotor has a Die plate 14 on with individual dies 16, which each have a pair of ram is assigned, namely an upper punch 18 and a lower punch 20. Die Press punches 18, 20 cooperate with stationary curve elements 22, which specify the position of the stamp in their rotation with the rotor 12 respectively.
  • FIG. 2 shows a pair of pre-pressure rollers 24 and a pair of main pressure rollers 26.
  • the pairs of pressure rollers 24, 26 lead with the help of the intermediate press punches the Compression of the powder material, as is known per se.
  • the powder material is a hopper 28
  • the powder material 30 in a filling shoe 32 is. This fills the individual matrices one after the other predetermined filling amount of powder, wherein the filling amount by the position of the Lower punch 20 in the dies 16 is determined. This too is known per se.
  • FIG. 2 also shows an NIR or LIF sensor 36, which is located above the Matrizenin 14 and arranged above the pitch circle of the dies 16 stationary is.
  • the mounting location of the sensor 36 is such that the respective upper punch itself already moved sufficiently far out of the die 16, so that sufficient Space for the sensor 36 is present.
  • the sensor 36 is shown. It is located in the press room of the tablet press 10, in which also the parts shown in Figure 2 are located.
  • the sensor 36 is connected to a computer 40, which in turn with a machine computer 42 for the tablet press works together.
  • a machine computer is in tablet presses known for the control and regulation of the operation.
  • the machine computer 42 cooperates with an operating computer 44, which also with the additional computer 40 is connected.
  • the shaft of the rotor (not shown) is a pulse generator 46 assigned, whose signals are given to the machine computer 42. Of the Pulse generator 46 is about a known angle encoder, in the smallest angle steps a corresponding signal to the machine computer 42 is for the Determining the position of the individual dies 16 of the rotor 12 (FIG. 2).
  • the ones from Sensor 36 detected data are evaluated in the additional computer 40 and in the Machine computer 42 given for the assignment to the individual tablets, which in the respective dies have been pressed. Conversely, the machine computer releases 42 an evaluation process position-dependent in the additional computer 40. The ad certain determined data takes place in the operating computer 44.
  • sensors are assigned to the tablet press.
  • One sensor 50 is assigned to the filling funnel 28, another sensor 52 to the filling tube from the funnel 28 to the filling shoe 32.
  • the filling shoe 32 is assigned a sensor 54.
  • a fourth sensor 50 is located immediately after the filling shoe 32.
  • Each of the sensors 50 to 56 which are in turn NIR or LIF sensors, allows a control of the powdery molding material 30 in the manner already described and way.

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  • Physics & Mathematics (AREA)
  • Health & Medical Sciences (AREA)
  • Spectroscopy & Molecular Physics (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • General Physics & Mathematics (AREA)
  • Immunology (AREA)
  • Pathology (AREA)
  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Optics & Photonics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Investigating, Analyzing Materials By Fluorescence Or Luminescence (AREA)
  • Investigating Or Analysing Materials By Optical Means (AREA)
  • Glanulating (AREA)
  • General Factory Administration (AREA)
EP04030542A 2004-02-20 2004-12-23 Méthode et dispositif pour le contrôle de qualité dans la fabrication de comprimés Active EP1568480B1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102004008321 2004-02-20
DE102004008321A DE102004008321B3 (de) 2004-02-20 2004-02-20 Verfahren und Vorrichtung zur Qualitätsüberwachung bei der Herstellung von Tabletten

Publications (3)

Publication Number Publication Date
EP1568480A2 true EP1568480A2 (fr) 2005-08-31
EP1568480A3 EP1568480A3 (fr) 2005-09-14
EP1568480B1 EP1568480B1 (fr) 2010-12-22

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EP04030542A Active EP1568480B1 (fr) 2004-02-20 2004-12-23 Méthode et dispositif pour le contrôle de qualité dans la fabrication de comprimés

Country Status (5)

Country Link
US (1) US7981352B2 (fr)
EP (1) EP1568480B1 (fr)
JP (1) JP4504221B2 (fr)
AT (1) ATE492394T1 (fr)
DE (2) DE102004008321B3 (fr)

Cited By (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1600761B1 (fr) * 2004-05-27 2007-07-11 Uhlmann VisioTec GmbH Presse pour comprimés avec dispositif intégré de détection à infrarouge proche
EP1810819A1 (fr) * 2006-01-18 2007-07-25 Fette GmbH Dispositif et procédé destinés à la surveillance de la production de tablettes dans une presse rotative
EP1844924A2 (fr) 2006-04-12 2007-10-17 Fette GmbH Procédé de régulation de la quantité d'agents actifs de tablettes pendant la production d'une presse rotative pour comprimés
EP2019306A1 (fr) * 2007-07-24 2009-01-28 Uhlmann VisioTec GmbH Système destiné à la fabrication et la surveillance de tablettes
WO2009137855A1 (fr) * 2008-05-13 2009-11-19 Universität Innsbruck Caractérisation de propriétés physico-chimiques d'une matière solide
EP2168761A3 (fr) * 2008-09-25 2012-12-12 Fette GmbH Procédé de surveillance de la qualité de matériaux de compression en poudre et une presse rotative destinée à l'exécution du procédé
US9713575B2 (en) 2009-05-07 2017-07-25 Gea Process Engineering Limited Tablet production module and method for continuous production of tablets
EP3219480A1 (fr) * 2016-03-16 2017-09-20 Kikusui Seisakusho Ltd. Organe de commande de machine de moulage par compression rotative
EP3363625A1 (fr) * 2017-02-15 2018-08-22 Kikusui Seisakusho Ltd. Dispositif d'alimentation en matériau pulvérulent et procédé d'alimentation de matériau pulvérulent
EP3385068A1 (fr) * 2017-03-07 2018-10-10 Robert Bosch GmbH Dispositif permettant de comprimer un produit
EP3165355B1 (fr) 2015-09-30 2021-07-14 Fette Compacting GmbH Procédé de fonctionnement d'une presse à comprimés à plateaux tournants
EP3978882A1 (fr) 2020-10-01 2022-04-06 Fette Compacting GmbH Agencement de capteur pour un dispositif de production, ainsi que procédé de transfert d'un capteur vers un boîtier d'un dispositif de production et à partir d'un boîtier d'un dispositif de production

Families Citing this family (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102006002359B4 (de) * 2006-01-18 2009-01-02 Fette Gmbh Vorrichtung und Verfahren zur Überwachung der Produktion von Tabletten in einer Rundläuferpresse
JP4642110B2 (ja) * 2006-07-13 2011-03-02 クオリテック株式会社 品質管理システム及び品質管理プログラム、並びにクライアント装置
WO2008072188A1 (fr) 2006-12-12 2008-06-19 Koninklijke Philips Electronics, N.V. Dispositif et procédé de communication qui fournit une période silencieuse pour une détection et une prévention
DE102007052552B4 (de) 2007-10-29 2010-01-07 Luxner, Peter, Dipl.-Ing. Verfahren und Vorrichtung zur Ermittlung von Steuer- und Regelparametern für Tablettenpressen
DE102008046422B3 (de) * 2008-09-09 2009-11-12 Fette Gmbh Verfahren zum Prüfen von Mehrschichttabletten in einer Mehrfachrundläuferpresse
WO2010043237A1 (fr) * 2008-10-14 2010-04-22 Siemens Aktiengesellschaft Procédé et système pour contrôler un comprimé et leur utilisation
JP5282960B2 (ja) * 2009-03-31 2013-09-04 アイシン・エィ・ダブリュ株式会社 駆動装置の情報管理システム及び駆動装置の製造方法
DE102010012198A1 (de) * 2010-03-19 2011-09-22 Erweka Gmbh Vorrichtung zum Ausrichten von Tabletten
DE102011101291B4 (de) 2011-05-10 2014-01-23 Fette Compacting Gmbh Druckeinrichtung für eine Presse und Rundläuferpresse
DE102011088909A1 (de) 2011-08-12 2013-02-14 Labtec Gmbh Verfahren zur Herstellung und Kontrolle von oralen Wirkstoff-Filmen
JP5918808B2 (ja) * 2014-06-23 2016-05-18 ジーイーエイ・ファーマ・システムズ・リミテッド 錠剤の製造モジュール及び錠剤の連続製造方法
CN105383085A (zh) * 2015-12-13 2016-03-09 秦皇岛博赫科技开发有限公司 模拟多元药物粉体压缩过程的压片机
JP6681764B2 (ja) * 2016-03-29 2020-04-15 株式会社菊水製作所 成形品製造システム
JP6752034B2 (ja) * 2016-03-29 2020-09-09 株式会社菊水製作所 粉体混合度測定装置、粉体混合供給システム、圧縮成形品を製造する方法
JP6775311B2 (ja) * 2016-03-29 2020-10-28 株式会社菊水製作所 成形品製造システム
EP3684322B1 (fr) * 2017-09-21 2022-04-20 F. Hoffmann-La Roche AG Installation de fabrication pharmaceutique et procédé de fabrication d'un produit pharmaceutique
JP7479659B2 (ja) * 2018-03-13 2024-05-09 株式会社菊水製作所 成形品搬送モジュール
DE102018222259A1 (de) 2018-12-19 2020-06-25 Robert Bosch Gmbh Steuereinrichtung für eine Einrichtung zur definierten Abgabe eines Klebstoffs und Verfahren zum Betreiben einer Einrichtung zur definierten Abgabe eines Klebstoffs
ES2972682T3 (es) * 2019-05-10 2024-06-14 Nestle Sa Prensa giratoria para comprimir un material alimentario
CN111923483B (zh) * 2020-10-09 2021-01-22 武汉大学人民医院(湖北省人民医院) 一种片状药片的挤压成型设备

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030042639A1 (en) * 2001-09-05 2003-03-06 Courtoy Nv Rotary tablet press and a method of cleaning such a press

Family Cites Families (25)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
BE791465A (fr) * 1971-11-16 1973-05-16 Upjohn Co Dispositif de prearmement pour pastilleuse
US3982865A (en) * 1974-03-21 1976-09-28 Hoffmann-La Roche Inc. Apparatus for high-speed accurate counting and handling of discrete objects such as tablets
US4570229A (en) * 1983-09-19 1986-02-11 Pennwalt Corporation Tablet press controller and method
JPS6154435A (ja) * 1984-08-24 1986-03-18 Kikusui Seisakusho:Kk 回転式有核錠剤機の核錠位置検出方法
GB8530365D0 (en) 1985-12-10 1986-01-22 Univ Bath Manufacture of moulded products
US4817006A (en) * 1986-03-28 1989-03-28 Thomas Engineering, Inc. Pharmaceutical tablet press control mechanism
US5023850A (en) * 1989-09-25 1991-06-11 Metts Rodney H Clock for keeping time at a rate other than human time
DE3939956A1 (de) * 1989-12-02 1991-06-06 Fette Wilhelm Gmbh Verfahren und einrichtung zum ueberwachen der presskraefte einer tablettiermaschine
JPH0447895A (ja) 1990-06-15 1992-02-18 Toshiba Corp 付加信号伝送・受信装置
JPH0810472Y2 (ja) * 1990-08-31 1996-03-29 塩野義製薬株式会社 回転式粉末圧縮成形機
JPH06273318A (ja) 1993-03-17 1994-09-30 Shokuhin Sangyo Intelligence Control Gijutsu Kenkyu Kumiai 粉体分析装置
US5504332A (en) * 1994-08-26 1996-04-02 Merck & Co., Inc. Method and system for determining the homogeneity of tablets
US5760399A (en) * 1995-10-02 1998-06-02 Foss Nirsystems, Inc. Measurement of transmission spectra of pharmaceutical tablets
US5838571A (en) * 1996-01-29 1998-11-17 Alza Corporation Tablet press monitoring and controlling method and apparatus
JP2802054B2 (ja) 1996-02-06 1998-09-21 株式会社菊水製作所 回転式有核錠剤機
US5781289A (en) * 1996-11-05 1998-07-14 Sabsabi; Mohamad Method and apparatus for rapid in situ analysis of preselected components of homogeneous solid compositions, especially pharmaceutical compositions
GB2347739A (en) * 1999-03-09 2000-09-13 Pfizer Ltd Powder Analysis
DE19911294C1 (de) * 1999-03-13 2000-06-15 Fette Wilhelm Gmbh Einstellverfahren für eine Rundläufertablettenpresse mit einem Winkelimpulsgeber zur Ermittlung des Preßkraftverlaufs an den einzelnen Stempeln in mindestens einer Preßstation
WO2001029539A1 (fr) * 1999-10-20 2001-04-26 Massachusetts Institute Of Technology Systemes et procedes destines a l'analyse par fluorescence de melanges
SE0000090D0 (sv) 2000-01-13 2000-01-13 Astrazeneca Ab Method and apparatus for monitoring
SE0000314D0 (sv) * 2000-01-31 2000-01-31 Astrazeneca Ab Apparatus and method for analysing
JP4030716B2 (ja) * 2000-11-01 2008-01-09 シーケーディ株式会社 錠剤の外観検査装置およびptp包装機
JP2002149222A (ja) * 2000-11-08 2002-05-24 Mitsubishi Electric Corp 製品の生産ラインにおける品質管理方法および品質管理システム
US6919556B1 (en) * 2002-02-22 2005-07-19 Monocle Technologies, Inc. System and method for monitoring and evaluating solid and semi-solid materials
US7057722B2 (en) * 2002-04-04 2006-06-06 Euro-Celtique S.A. Method and apparatus for determining the homogeneity of a granulation during tableting

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030042639A1 (en) * 2001-09-05 2003-03-06 Courtoy Nv Rotary tablet press and a method of cleaning such a press

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
BRUKER OPTICS: "Opticsnews, v 4.1.2003" INTERNET ARTICLE, [Online] 2003, XP002335119 Gefunden im Internet: URL:http://www.brukeroptics.de/downloads/opticsnews_vol4_1-2003.pdf> [gefunden am 2005-07-06] *
LAI, C-K AND COONEY, CC: "Application of a fluorescence sensor for miniscule on-line monitoring of powder mixing kinetics" JOURNAL OF PHARMACEUTICAL SCIENCES, Bd. 93, Nr. 1, 2003, Seiten 60-70, XP002335118 *
LAI, C-K, ET AL: "Nondestructive and on-line monitoring of tablets using light-induced fluorescence technology" PHARMASCITECH, [Online] 2003, XP002335117 AAPS Gefunden im Internet: URL:http://www.aapspharmscitech.org/articles/pt0501/pt050103/pt050103.pdf> [gefunden am 2005-06-06] *

Cited By (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1600761B1 (fr) * 2004-05-27 2007-07-11 Uhlmann VisioTec GmbH Presse pour comprimés avec dispositif intégré de détection à infrarouge proche
EP1810819A1 (fr) * 2006-01-18 2007-07-25 Fette GmbH Dispositif et procédé destinés à la surveillance de la production de tablettes dans une presse rotative
EP1844924A2 (fr) 2006-04-12 2007-10-17 Fette GmbH Procédé de régulation de la quantité d'agents actifs de tablettes pendant la production d'une presse rotative pour comprimés
DE102006017196A1 (de) * 2006-04-12 2007-10-25 Fette Gmbh Verfahren zur Regelung der Wirkstoffmenge von Tabletten während der Produktion in einer Rundläufertablettenpresse
EP1844924A3 (fr) * 2006-04-12 2008-09-03 Fette GmbH Procédé de régulation de la quantité d'agents actifs de tablettes pendant la production d'une presse rotative pour comprimés
DE102006017196B4 (de) * 2006-04-12 2008-09-11 Fette Gmbh Verfahren zur Regelung der Wirkstoffmenge von Tabletten während der Produktion in einer Rundläufertablettenpresse
US7471992B2 (en) 2006-04-12 2008-12-30 Fette Gmbh Method for the automatic control of the amount of active ingredient of tablets during the production in a rotary tablet press
EP2023122A2 (fr) 2007-07-24 2009-02-11 Uhlmann Visio Tec GmbH Système de vérification de tablettes
EP2019306A1 (fr) * 2007-07-24 2009-01-28 Uhlmann VisioTec GmbH Système destiné à la fabrication et la surveillance de tablettes
WO2009137855A1 (fr) * 2008-05-13 2009-11-19 Universität Innsbruck Caractérisation de propriétés physico-chimiques d'une matière solide
EP2168761A3 (fr) * 2008-09-25 2012-12-12 Fette GmbH Procédé de surveillance de la qualité de matériaux de compression en poudre et une presse rotative destinée à l'exécution du procédé
US8568630B2 (en) 2008-09-25 2013-10-29 Fette Gmbh Rotary press for quality surveillance of powdered pressed material
US9713575B2 (en) 2009-05-07 2017-07-25 Gea Process Engineering Limited Tablet production module and method for continuous production of tablets
US10016340B2 (en) 2009-05-07 2018-07-10 Gea Process Engineering Limited Tablet production module and method for continuous production of tablets
EP3165355B1 (fr) 2015-09-30 2021-07-14 Fette Compacting GmbH Procédé de fonctionnement d'une presse à comprimés à plateaux tournants
EP3219480A1 (fr) * 2016-03-16 2017-09-20 Kikusui Seisakusho Ltd. Organe de commande de machine de moulage par compression rotative
EP3363625A1 (fr) * 2017-02-15 2018-08-22 Kikusui Seisakusho Ltd. Dispositif d'alimentation en matériau pulvérulent et procédé d'alimentation de matériau pulvérulent
EP3385068A1 (fr) * 2017-03-07 2018-10-10 Robert Bosch GmbH Dispositif permettant de comprimer un produit
EP3978882A1 (fr) 2020-10-01 2022-04-06 Fette Compacting GmbH Agencement de capteur pour un dispositif de production, ainsi que procédé de transfert d'un capteur vers un boîtier d'un dispositif de production et à partir d'un boîtier d'un dispositif de production

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Publication number Publication date
US20050184435A1 (en) 2005-08-25
EP1568480A3 (fr) 2005-09-14
DE102004008321B3 (de) 2005-11-17
EP1568480B1 (fr) 2010-12-22
JP4504221B2 (ja) 2010-07-14
ATE492394T1 (de) 2011-01-15
US7981352B2 (en) 2011-07-19
DE502004012022D1 (de) 2011-02-03
JP2005233959A (ja) 2005-09-02

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